Medical Device Components  ·  ISO 9001 / ISO 13485

Quality records that hold up under scrutiny.

QALogger gives small medical device component manufacturers a complete digital quality logbook — inspection records, corrective actions, calibration, supplier quality, and document control. Built for ISO 9001 and ISO 13485 environments.

🔒 Your records never leave your device — no cloud, no server, no data exposure.

ISO 13485 aligned Full audit traceability Works offline 8 quality apps $499 one-time

Buy QALogger — one-time purchase

One payment of $499 — a perpetual license, no subscription. Backed by a 30-day money-back guarantee.

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One-time purchase  ·  30-day money-back guarantee  ·  Privacy policy

Everything a medical device shop needs

🔬
Inspection Log
In-process and final inspection records with full traceability. Timestamped and user-attributed.
📋
Non-Conformance Reports
Log, investigate, and close out NCRs with root cause analysis and corrective actions linked.
🏭
Supplier Quality Log
Approved vendor list, incoming material quality records, and supplier performance tracking.
📐
Calibration Log
Equipment calibration schedule and history. Reminders before due dates so nothing slips.
📁
Document Control
Controlled documents, revision history, approval status, and distribution records.
📶
Works Offline
Log records anywhere — no Wi-Fi required. All data saves locally on your device.

ISO 9001:2015 clause coverage — out of the box

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